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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018847
Receipt No. R000021799
Scientific Title Continuous Epidural Contrast
Date of disclosure of the study information 2015/09/01
Last modified on 2016/09/04

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Basic information
Public title Continuous Epidural Contrast
Acronym CEC
Scientific Title Continuous Epidural Contrast
Scientific Title:Acronym CEC
Region
Japan

Condition
Condition The patients required for the CT-guide procedure such as embolism of liver artery and radiofrequency of liver, which needed the epidural analgesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the possibility of continuous epidural contrast according to the diagnosis by authorized radiologists through the CT scan at the end of the procedure. We will also clarify the possibility of continuous epidural contrast changing the concentration of contrast at the same time.We will collect the information regarding the safety whether to mixture the contrast with the anesthetics (0.75% ropivacaine) from the start of surgery until the end.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Our main outcome would be the possibility of continuous epidural contrast according to the diagnosis by authorized radiologists through the CT scan at the end of the procedure.
Key secondary outcomes We will collect the information regarding the safety whether to mixture the contrast with the anesthetics (0.75% ropivacaine). In addition to that, we will collect the side effects or deleterious information regarding this research such as allergy of contrast.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 anesthetics
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with acquired consent
2) Conscious patients enable to do the conversation
Key exclusion criteria 1) allergy for contrast
2) Renal dysfunction (Serum Creatinin 2.0 mg/dL)
3)Liver dysfunction (Serum AST/ALT >100 mg/dL)
4)Severe Heart dysfunction (Ejection fraction <40%)
5)Convulsion
6)Severe asthma
7)Thyroid dysfunction
8) Diabetes using the medicine piganaid

Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Matsusaki
Organization Okayama University Hospital
Division name Intensive Care Unit
Zip code
Address 2-5-1 Kitaku Shikatacho
TEL +819013223409
Email matusakik@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Matsusaki
Organization OKAYAMA UNIVERSITY HOSPITAL
Division name Intensive Care Unit
Zip code
Address 2-5-1 Kitaku Shikatacho
TEL +819013223409
Homepage URL
Email matusakik@ybb.ne.jp

Sponsor
Institute Department of Anesthesiology and Resuscitology
Institute
Department

Funding Source
Organization Department of Anesthesiology and Resuscitology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 岡山大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Continuous epidural contrast was feasible.
0.75% ropivacain, omnipark and saline facilitated contrast's assessment.
The clinical outcome was not consistent with the contrast.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2016 Year 08 Month 22 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 09 Month 03 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 29 Day
Last modified on
2016 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021799

Research Plan
Registered date File name
2016/09/03 硬膜外持続造影研究計画書_最終0817.docx

Research case data specifications
Registered date File name
2016/09/03 Excelシート(データ)持続硬膜外造影.xlsx

Research case data
Registered date File name
2016/09/03 持続造影まとめ.UMIN.pptx


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